FDA.reportPublic FDA data

Simethicone 125mg Gas Relief

Manufacturer
One2Zee Limited Liability Company
Effective date
2026-09-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-09-08 02:01:23

Label at a glance#

ProductSimethicone 125MG Gas Relief
Active ingredientDIMETHICONE
Label structure9 sections

Dosage and administration

adults:swallow with water 1 or 2 softgels as needed after meals and at bedtime do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

Storage and handling

store at controlled room temperature 20°-25°C (68°-77°F) protact from light, heat and moisture do not use if imprinted safety seal under cap is broken or missing

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each softgel)

Simethicone 125 mg

OTC - PURPOSE SECTION

Purpose

Antigas

INDICATIONS & USAGE SECTION

Use for the relief of

  • pressure
  • bloating
  • fullness
  • commonly referred to as gas

Warning

WARNINGS SECTION

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults:swallow with water 1 or 2 softgels as needed after meals and at bedtime
  • do not exceed 4 softgels in 24 hours except under the advice and supervision of a physician

Other Information

STORAGE AND HANDLING SECTION

  • store at controlled room temperature 20°-25°C (68°-77°F)
  • protact from light, heat and moisture
  • do not use if imprinted safety seal under cap is broken or missing

INACTIVE INGREDIENT SECTION

D&C yellow 10, FD&C blue 1, FD&C red 40, gelatin, glycerin, povidone, peppermint oil, purified water, sorbitol, titanium dioxide

OTC - QUESTIONS SECTION

Questions or comments?
Call 1-833-663-2933

Principal Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bottle labelbottle label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55629-02155629-021-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OACTIB
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POVIDONEFZ989GH94EIACT
PEPPERMINT OILAV092KU4JHIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12024-09-25full-release2026-06-01 00:22:11

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Simethicone 125MG Gas ReliefSIMETHICONE 125 MGOne2Zee Limited Liability Company0df348bf-5a07-4f36-ae70-ca2961a9ce7e2026-09-04WarningsExact identifier
ndc (package): 55629-021-01
ndc (product): 55629-021
ndc11 (package): 55629002101
spl id: 84fec012-9895-4286-af72-d08b054837d5
spl set id: 0df348bf-5a07-4f36-ae70-ca2961a9ce7e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.